Wednesday, May 14, 2014

CASAA Submission to U.S. Senate Committee on Health, Education, Labor, and Pensions Regarding 5-15-14 Hearing on E-Cigarettes



To:          Members of the Senate Health, Education, Labor, and Pensions Committee

From:    The Consumer Advocates for Smoke-free Alternatives Association

Re:         May 15, 2014 Hearing on E-Cigarettes

Date:     May 14, 2014

The Consumer Advocates for Smoke-free Alternatives Association (CASAA)[1] has serious concerns about the hearing involving e-cigarettes scheduled for Thursday, May 15th. Specifically, we believe that inviting Dr. McAfee and Mr. Zeller as the sole witnesses will not offer well-rounded or even completely accurate information.

CASAA asks for your help in ensuring that the Senate hearing is not simply a platform for CDC and FDA to present misinformation, unchallenged.

Both CDC and FDA have demonstrated they are intent on reducing the availability, quality, and use of e-cigarettes. They are apparently unconcerned that e-cigarettes have proven to be an effective method for hundreds of thousands of American smokers to quit smoking, substituting an alternative that is estimated to be 99% less harmful than smoking. Often this substitution worked for them after every other method of quitting smoking failed. Indeed, these agencies are willing to mislead the American public into believing that e-cigarettes are highly hazardous and are not helping people quit. They have repeatedly presented misleading interpretations of data and are paying to have misleading data created. There have been hundreds of analyses written that show how these agencies have systematically misled the American people, and we expect they will attempt to do the same to Congress.
 
CDC Director Frieden has aggressively dismissed the evidence that people have quit smoking using e-cigarettes as “anecdotes.”[2] These “anecdotes” he dismisses include tens of thousands of heart-wrenching stories of people who tried to quit smoking, often using every method recommended by CDC, and failed until they discovered e-cigarettes. CASAA has collected and published over 6,000 such individual stories, and other ad hoc collections include a thousands more. Moreover, the reason that we do not have systematic population data about what portion of American smokers have quit using e-cigarettes is because CDC and other units of the Department of Health and Human Services, which normally collect such data, have avoided doing so. Systematic studies in France and the United Kingdom, where e-cigarettes are only slightly more popular than they are here, have estimated that as much as 1% of the population (1% of the whole population, not 1% of smokers) have quit smoking by using e-cigarettes. This would make the free market in e-cigarettes more important for smoking cessation than anything CDC, FDA, or any other government agency has done for decades.

Despite denigrating the thousands of honest and informative success stories as “mere anecdotes,” CDC is now paying to find genuinely uninformative anecdotes: a handful of people who, despite cutting back or eliminating smoking via a low-risk alternative, nonetheless developed a serious illness that is sometimes caused by smoking.[3] CDC is ostensibly looking for "real people to appear in ads about the health effects of smoking cigarettes" who are ex-smokers who:

  • For at least a year, used e-cigarettes or smokeless tobacco while continuing to smoke some cigarettes; and
  • Thought using e-cigarettes or smokeless tobacco to cut back on some cigarettes would be good for your health; and
  • Despite cutting back, you were later diagnosed with a serious health condition.

There can be no purpose to this kind of recruitment other than to insinuate that adult smokers who choose to use e-cigarettes or smokeless tobacco are not reducing their risks. This would involve intentionally ignoring their own estimates that most people who die from smoking do so after they quit, often many years later; instead they appear poised to attribute the disease to their recent behavior rather than their long-term history of smoking.

We understand, of course, the problems from a regulatory standpoint of manufacturers making therapeutic or modified risk claims. However, there is a big difference between prohibiting manufacturers from informing their customers of potential health benefits associated with switching to e-cigarettes or smokeless tobacco versus the government actively misleading and misinforming the public about those risks. As consumer representatives, we believe this is a shocking breach of faith.

CDC has also misrepresented data regarding e-cigarette use by children.[4] Clearly, the agenda is to report the data in a distorted manner so as to justify draconian regulation of e-cigarettes in order to "save the children." (CASAA supports bans on sales to minors, but opposes restrictions that serve primarily to reduce the availability, affordability, or quality of these potentially life-saving products for adult consumers.)

In an interview with the Los Angeles Times[5], Dr. Frieden stated, "The challenge that the FDA has is that they will be challenged by the tobacco industry, as they have been at every step of the way," and he then went on to say that FDA "tried to regulate e-cigarettes earlier, and they lost to the tobacco industry. . . . So the FDA has to balance moving quickly with moving in a way that's going to be able to survive the tobacco industry's highly paid legal challenge." 

The lawsuit he alluded to was waged by two small (at the time) e-cigarette companies which were not at all affiliated with any of the traditional tobacco companies, contrary to Dr. Frieden’s explicit claim. In fact, the traditional tobacco companies are latecomers to the e-cigarette market, jumping in after the market had been developed by a consumer-driven e-cigarette industry. He claims that the tobacco industry is the threat to the recently proposed regulations, but it is generally acknowledged that the barriers to commerce created by the proposed regulations are so high that it is only the large tobacco companies that will be able to stay in the market. It is their competition from outside the traditional tobacco sector -- small businesses who make higher-quality products that consumers prefer -- that would be forced out of business by the burden of “red tape” requirements that create no apparent benefits. Thus, the opposition to the regulations is coming primarily from consumer and small businesses, not the traditional tobacco industry.[6]

There are possibly regulations that would be genuinely beneficial to the American people. However, it does not appear that the proposed regulations would serve any such purpose (other than banning sales to children, which most states already do or will do soon). While the stated justifications for the regulations acknowledge a few of these genuinely beneficial actions (like protecting against contamination or poor manufacturing practices), the proposed regulations actually do nothing to address those issues.

We are further concerned about FDA's apparent lack of understanding of the relevant science. In addition to proposing regulations that would completely destroy the diversity in the marketplace -- eliminating the quality and variety that make e-cigarettes such an effective alternative for adult smokers -- the draft regulation documents are filled with misleading scientific claims that are either only vaguely supported by cherry-picked evidence or not supported at all. We have only just begun to document these,[7] but expect to generate hundreds of pages of analysis about the false and misleading scientific claims in these regulation documents.

The content of the proposed regulations downplays all of the positive evidence about e-cigarettes (as we began to document[8]), while blindly accepting negative claims. Perhaps most notably, CASAA provided a research grant (funded by donations from our membership) to a professor at Drexel University. He reviewed all the available evidence about the chemicals e-cigarette users and bystanders are exposed to, and he concluded (based on the extensive science that exists about such exposures) that the risks from all the measured chemicals are trivial. A preliminary version of this report has been available for almost a year and was very widely discussed (which is to say, FDA obviously knew about it and its importance for a very long time; we gave it to them ourselves) and it was published in a peer-reviewed academic journal[9] well before FDA released their draft regulation. It is the single most important analysis on the topic, and yet it is not mentioned in the ostensibly scientific analysis in the draft regulation which includes nearly 200 other references.

CDC and FDA -- and Senator Harkin -- frame this as a battle between government (supposedly representing the interests of the public) versus so-called "Big Tobacco." The truth, however, is that the CDC and the FDA have demonstrated a shocking disregard of the interests of consumers, the single most important stakeholder in this entire process. The people who matter the most in all of this are those who use (or in the future may use) e-cigarettes as a low-risk alternative to smoking. The American people are being completely ignored. Moreover, as noted previously, imposing almost insurmountable burdens on "industry" has the effect of destroying the diverse marketplace that has allowed millions of people worldwide to eliminate or reduce their smoking habit, and then hand what remains of the sector to those very companies they denigrate as “Big Tobacco.”

Central to CASAA's mission is the importance of providing truthful and accurate information so that people can make informed choices, and also so that those entrusted with the responsibility of governance can make responsible legislative and regulatory policy. CASAA is the leading representative of the growing population of politicized American e-cigarette users; we estimate that as many as a few hundred thousand of them have become single-issue voters passionately interested in protecting their access to e-cigarettes. It is that important to them. We understand that testimony will be limited to CDC and FDA at this hearing. However, we respectfully request that should any future hearings occur, we be given an opportunity to present testimony on behalf of consumers.

On behalf of our membership, we respectfully request your help in making sure that the interests of consumers -- both current users of low-risk alternatives to smoking such as e-cigarettes, as well as those who may choose to use those products in the future -- are represented in this hearing.




Sincerely,


Julie Woessner, President
The Consumer Advocates for Smoke-free Alternatives Association (CASAA)
CASAA.org
jwoessner@casaa.org
(202) 241-9117
(919) 698-7931





[1] By way of background, CASAA is a non-profit 501(c)(4) NGO, providing public health science and public education. We are an all-volunteer organization with a grassroots membership of nearly 20,000 individuals from all walks of life. We are a consumer advocacy organization, not a trade association or industry representative. CASAA is dedicated to ensuring the availability of low-risk alternatives to smoking and to providing smokers and nonsmokers alike with honest information about those alternatives. Since CASAA's founding in 2009, we have educated the public and increased awareness about the benefits of low-risk alternatives to smoking, including e-cigarettes. We also advocate for responsible legislative policy designed to improve public health by recognizing that smoke-free nicotine-containing products are inherently far less hazardous than smoking.

[2] Examples of Dr. Frieden's aggressive dismissal of thousands of “anecdotes” can be found in the Los Angeles Times http://www.latimes.com/science/sciencenow/la-sci-sn-why-tom-frieden-hates-electronic-cigarettes-cdc-20140429-story.html and an interview with NPR http://www.npr.org/templates/transcript/transcript.php?storyId=306542127.

[3]Recruitment ad sponsored by CDC: http://www.plowsharegroup.com/TipsAdRecruitment/

[4] A discussion of this issue by CASAA’s Scientific Director, Dr. Carl V. Phillips, can be found here:  http://antithrlies.com/2013/09/07/cdc-lies-about-kids-using-e-cigarettes/. (See also an analysis by CASAA Director Elaine Keller of claims made by Dr. Frieden in an interview with Medscape last year, http://antithrlies.com/2013/10/08/cdc-director-misleads-medscape/.)

[6] See CASAA's preliminary analysis of the proposed FDA regulations:  http://blog.casaa.org/2014/04/casaa-assessment-of-fda-deeming.html.

15 comments:

Alisha Christian said...

Thank you so much!

Claudia Linse said...

Yes, thank you, Julie and CASAA. I feel so helpless throughout this process and you've given me a voice.

Anonymous said...

Julie & Everyone Else at CASAA,

Thanks for another fabulous articulate argument on our behalf!

Pat Meyer

Glenn Wakefield said...

Nicely phrased. Well done! Thank you!

Megan Burgess said...

Thanks you Julie and all at CASAA!! As asked by the earlier CASAA email, I submitted my personal story also in a letter for the hearing tomorrow,

Kent Brooks said...

Fantastic article Julie, well done!!

~Clark from Nicoticket

Florida_Vaper said...

I contacted Senator Harkin's office via online form to cite The Drexel University Department of Public Health study (PRNewswire excerpt) to please give higher weight to the newest scientific research proving that there are no second hand vapor exposure effects, unlike tobacco cigarettes, since e-liquid is prepared with USP nicotine, just like Nicorette gum and NRTs, e-cigarettes are not a tobacco product, and such gums and lozenges have been on the market for 12+ years with candy flavorings and despite this, there have been no surges in minor uptake of Nicroette or nicotine lozenge addiction. Please do not let this hearing devolve into a witch hunt against this nascent industry that is saving the lives of ex-smokers and is at least 95% healthier than smoking.

Scott Javens said...

Thank you CASAA for representing those of us who have relied on e-cigarettes to quit smoking! You are welcome to add my testimony to the list if you like.
I smoked cigarettes for about 22 years, and it was something I enjoyed, and had no desire to quit. Every year, it got more and more expensive, and I had gotten up to 2 and a half packs a day, sometimes more, and was spending over $200 a month on it. I quit mainly for financial reasons, and e-cigarettes were a MUCH cheaper alternative. I couldn't have done it without them! I bought an eVod kit for $60, and finished the pack of cigarettes I had left, and I haven't picked up another cigarette since. This was October 17th 2013. I am now nearly 7 months smoke free. I upgraded my equipment, and I love the available flavors. I tried the "gas station" style e-cigs, and didn't like them at all. I prefer the high end equipment that I get from my local vape shop. I can breathe again, I no longer cough constantly, I have more energy, and I have even lost weight. Not to mention I no longer smell like a stale ashtray, and neither do my house or my kids. E-cigarettes have quite possibly extended my life, and stopped my kids from enduring second hand smoke. I intend to continue vaping as long as they are available and affordable.

Richard Bennett said...

Yes, thank you, Julie and CASAA --Thanks for another argument on our behalf!

Unknown said...

Here is a link to a very illuminating report on this subject from Dr. Lynne Dawkins, Experimental Psychologist and Director of the Drugs and Addictive Behaviors Research Group at the University of East London, UK.

A public lecture on e-cigarettes was delivered by Dr. Dawkins. This lecture gives an introduction to e-cigarettes, what they are and how they work. It then brings the audience up to date with the current research: who uses them, how and why, nicotine content and delivery, safety issues, harm reduction and regulation.

http://www.uel.ac.uk/ecigarettelecture

Howard Sloane said...

I call for all to donate at the minimum, the cost of a pack of cigarettes in your local area (in my case $13.) to CASAA.

Confirmation number: 20L9624xxxx124114
Donation amount: $13.00 USD
Total: $13.00 USD
Purpose: Consumer Advocates for Smoke-free Alternatives Association
Reference: CASAA Donation
Contributor: HMS WebWorks
Message: Donating the cost of a pack of cigarettes where I live

WJU said...

Thank you CASAA board members for all of your hard work, especially considering it is a volunteer effort. I have written my senator asking that Julie and Carl be called to testify on vaping to the HELP committee.

Allison Taylor said...

Wondreful!

WJU said...

Excellent letter, Julie. I have copied it and I'm printing it out and giving it to all the local vendors I am soliciting to display the CASAA 8 x 10 banner with business cards.

Dan az said...

I just received this from ebay where I was selling mods and tanks, And I just wanted everyone to know that they are taking sides of the FDA ruling that was shut down by congress of trying to control the ecig market. I closed my account with them and I hope everyone else will do the same to send a message to them.I explained that the FDA was shut down on their attempt to control the market on false information by congress and that because of their apparent liberal decision to follow through with it anyway they have made a 3 million consumer mistake. Write them and tell them why you are shutting down your account and take a stand before it goes any further.We need to stand together on this one.
The following listing has been removed:

181431343545 - Innokin VTR, Stainless Steel with case


We noticed that item(s) offered for sale on this account weren’t listed in accordance with our Tobacco Products policy. We realize you may not have been aware of this policy, or that this may have been a simple oversight, so we're including some policy information to help you with your future listings and to make sure they don't run into any problems. We also had to take the following actions:
- Listings that didn't follow eBay guidelines have been removed. A list of removed items is available further down in this email.
- We have credited any associated fees to your account.
Due to strict government regulations, eBay doesn't allow the sale of most tobacco products. This includes cigarettes, cigars, electronic cigarettes (e-cigarettes), herbal cigarettes, and smokeless tobacco.

The following items are not considered collectibles, and they are not allowed to be listed or sold on eBay:
- Cigars in cellophane wrapping
- Collectible tobacco, including a listing that describes the tobacco instead of its collectible packaging
- Tobacco products packaged in classic packaging
- Electronic cigarettes (e-cigarettes) or e-cigarette accessories

You may sell collectible packaging that contains tobacco if the package is unopened. Your listing must follow the guidelines below, and the guidelines must be included in the listing. Please refer to the policy page to find the guidelines and disclaimers you need to include in your listing.

If you include photos in your listing, you need to display the actual item for sale. Stock photos are not allowed.

For more information on this policy, go to:
http://pages.ebay.com/help/policies/tobacco.html

You listed an electronic cigarette or an electronic cigarette accessory. While we appreciate that you have chosen to utilize our site, we must ask that you please not relist in this case. We attempted to call you to go over this information by phone but were unable to reach you.

Please take a moment to familiarise yourself with this information and be sure that future listings follow these guidelines. Keep in mind that if further items aren't listed in accordance with our policy, it could result in additional action including account restrictions or loss of buying and selling privileges on eBay.


Learn more about the reasons why listings are removed:
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